For each device type or family there must be a file holding or pointing to the device specifications, the production process and quality assurance specifications and procedures, traceability requirements, the packaging and labelling specifications and, where relevant, installation and servicing requirements, with the extent of traceability set according to the risk if the device fails requirements. Australia: labelling and instructions must meet Essential Principle 13, including UDI information where applicable, and implant cards and patient leaflets must meet EP 13A (UDI optional on leaflets). Brazil: procedures must keep labels, instructions and packaging intact and prevent mix-ups, and labels must stay legible and attached through processing, storage, handling and use (RDC 665/2022 Arts 85, 86). Canada: objective evidence of safety and effectiveness must be kept (CMDR 9(2)); labels for Canada must meet the English and French requirements and show manufacturer details, device identifier, a control number for Class III and IV devices, contents, sterility, expiry, intended use, directions and storage conditions (CMDR 21 to 23); and distribution records must allow complete and rapid withdrawal (CMDR 52 to 56). Clauses: ISO 13485:2016 4.2.1, 4.2.3, 7.1, 7.5.8, 7.5.9.1; MO169 Arts 6, 7-2, 26, 47, 48.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.